CONRAY 30 SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IOTHALAMATE MEGLUMINE

Available from:

LIEBEL-FLARSHEIM CANADA INC

ATC code:

V08AA04

INN (International Name):

IOTALAMIC ACID

Dosage:

300MG

Pharmaceutical form:

SOLUTION

Composition:

IOTHALAMATE MEGLUMINE 300MG

Administration route:

INTRAVASCULAR

Units in package:

100/150/250ML

Prescription type:

Ethical

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0102763002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-03-14

Summary of Product characteristics

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_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CONRAY
®
30
(Iothalamate meglumine injection USP 30% w/v)
CONRAY
®
43
(Iothalamate meglumine injection USP 43% w/v)
CONRAY
®
60
(Iothalamate meglumine injection USP 60% w/v)
IONIC IODINATED RADIOGRAPHIC CONTRAST MEDIUM FOR INTRAVASCULAR USE
Liebel-Flarsheim Canada Inc.
7500 Trans-Canada Highway
Pointe-Claire, QC, H9R 5H8
CANADA
Date of Revision:
December 27,
2017
Submission Control No: 205718
_ _
_ _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL INFORMATION
..........................................................................29
DETAILED PHARMACOLOGY
.....................................................................................30
TOXICOLOGY
.